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Trial record 78 of 2357 for:    "Diabetes Mellitus, Insulin-Dependent"

Comparison Between GLP 1 Analogues and DPP 4 Inhibitors in Type 1 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01235819
Recruitment Status : Completed
First Posted : November 8, 2010
Last Update Posted : July 27, 2016
Information provided by (Responsible Party):
KVS Hari Kumar, Command Hospital, India

Brief Summary:
To study the effects of GLP 1 analogues and DPP 4 inhibitors on newly detected type 1 diabetes patients.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Insulin Drug: Sitagliptin Drug: Exenatide Phase 4

Detailed Description:
Inclusion criteria T1DM <3 months GAD Antibody+ Stimulated C peptide<0.5ng/ml Ketosis at onset Age < 30 yr Exclusion criteria Age > 30 yr Pancreatic disease significant systemic complication

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between GLP 1 Analogues and DPP 4 Inhibitors in Type 1 Diabetes Mellitus
Study Start Date : November 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Active Comparator: Insulin alone
Type 1 DM only on Insulin
Drug: Insulin
Exenatide Sitagliptin
Other Name: Premixed Insulin

Active Comparator: Insulin and Exenatide
Newly detected Type 1 DM on Insulin and exenatide
Drug: Exenatide
Exenatide 10 micrograms daily twice
Other Name: GLP 1 analogues

Active Comparator: Insulin and Sitagliptin
Newly detected Type 1 DM using Insulin and Sitagliptin
Drug: Sitagliptin
Sitagliptin 100 mg per day oral
Other Name: DPP 4 inhibitors

Primary Outcome Measures :
  1. change in insulin requirement [ Time Frame: one year ]
    To assess the change in insulin requirement with use of GLP 1 analogues or DPP 4 inhibitors along with insulin in type 1 diabetes

Secondary Outcome Measures :
  1. C peptide response [ Time Frame: at the end of one year ]
    To assess the endogenous insulin secretion after one year of use of GLp 1 analogue and DPP 4 inhibitors

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • T1DM <3 months
  • GAD Antibody+ or Stimulated C peptide<0.5 ng/ml
  • Ketosis at onset
  • Age < 30 yr

Exclusion Criteria:

  • Age > 30 yr
  • Pancreas disease
  • Significant systemic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01235819

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Command Hospital
Lucknow, UP, India, 226002
Sponsors and Collaborators
Command Hospital, India
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Study Director: The Commandant, MD Command Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: KVS Hari Kumar, Endocrinologist, Command Hospital, India Identifier: NCT01235819     History of Changes
Other Study ID Numbers: DM/CHCC/03/2010
First Posted: November 8, 2010    Key Record Dates
Last Update Posted: July 27, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not permitted

Keywords provided by KVS Hari Kumar, Command Hospital, India:
type 1 diabetes

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Sitagliptin Phosphate
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents